Archive for the 'Pharma' Category

20
Nov
08

Bush, Obama and why Wyeth v. Levine is so important

Doug Kendall, founder and President of the Constitutional Accountability Center, puts the Wyeth v. Kendall case currently before the Supreme Court into a broader context, and analyzes how presidential politics has contributed to – and may ultimately change – the way product liability litigation against pharmaceutical companies are decided.

Kendall notes that this case is an illustration of both “the importance of Supreme Court rulings to ordinary Americans and the aggressive efforts of the outgoing Administration to use the Court and its own regulatory authority to protect corporations from being held accountable for the harms caused by their products.”

As he goes on to explain, the Federal Food, Drug & Cosmetic Act (FDCA), the federal statute governing drug approval, labeling and safety regulations, is the relevant statute in this case. But when it was originally enacted by Congress back in 1938, all remedies available to consumers under state law were consistent with the FDCA, unlike today where there are numerous conflicts between federal law and the law in each state (as is the case in Vermont).

In the past seventy years, Congress has amended the statute numerous times, and yet has managed to avoid addressing the critical issue of whether the FDCA expressly preempted state law claims against pharmaceutical companies such as Wyeth in this case. Kendall does point out, however, that it did choose to include an “express preemption clause regarding medical devices” (as per Riegel v. Medtronic).

This revision of long-standing FDA policy on preemption in the drug labeling context was made over the objection of career agency officials, including the highest official in the drug review process, who warned that “much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”  [. . .]

According to a report released today by the House Committee on Oversight and Government Reform, “the White House played a significant role in the preemption provisions and pressured the agency to reject the concerns of career experts.”

This attempt to achieve “preemption by preamble” not only places Americans’ health and safety at risk, but it also circumvents Congress and the Constitution–the Supremacy Clause, after all, states that the laws of the United States are supreme, not federal agency preambles.

But here is where it gets really interesting: Could the Bush Administration’s policy of “preemption by preamble” be reversed next year, regardless of the high court’s ruling? Kendall argues that: 

“A top priority of the new administration should be to review the preemption decisions by the Bush Administration and reverse them unless Congress has declared clearly in federal law its intent to displace state law. And Congress can overturn any holding by the Court in Wyeth, as well as a long-list of other bad preemption decisions by the courts in recent years, by amending the laws in question and clarifying that the states should not be inappropriately displaced by federal law.”

The Court needs to do its job and rule for Diana Levine in Wyeth. But the results of the election held the day after the Wyeth argument should have an equally great impact on the ability of states to serve as laboratories of democracy and the availability of remedies for individuals who are harmed by corporate wrongdoing.

It has been reported that the court is not expected to rule on the case until next June, and that the justices are “torn” over how they will make their decision, and yet the most important question to ask is actually whether the incoming Obama administration and new Congress will decide to take Kendall’s advice and push forward legislation that will effectively reverse a potential ruling in favor of the defendant.

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